When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to sirolimus.

How to Use This Medicine:
Liquid, Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Take this medicine the same way every day. This means take it at the same time and take it consistently, either with or without food.
• Tablet: Swallow whole. Do not crush, break, or chew it. Tell your doctor if you cannot swallow the tablet.
• Oral liquid:
  
  • Use the syringe that comes with the package to measure the dose. Empty the medicine from the syringe into a cup and mix it with at least 2 ounces (¼ cup or 60 mL) water or orange juice. Do not use any other liquids. Drink it right away. Add another 4 ounces (½ cup or 120 mL) of water or orange juice to the cup, stir again, and then drink it right away to make sure you have taken all the medicine.
  • If you get any of the oral liquid on your skin, wash the area with soap and water. If you get it in your eyes, rinse them with water.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Store the oral liquid in the refrigerator. Do not freeze. If the medicine becomes cloudy, leave it out until it is at room temperature then shake it until the haze disappears. You may store the oral liquid at room temperature for no longer than 15 days. Throw away any unused medicine after 30 days.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how sirolimus works. Tell your doctor if you are using any of the following:
  
  • Amphotericin B, boceprevir, bromocriptine, carbamazepine, cimetidine, cisapride, clarithromycin, clotrimazole, cyclosporine, danazol, diltiazem, erythromycin, fluconazole, indinavir, itraconazole, ketoconazole, metoclopramide, nicardipine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, ritonavir, St John wort, telaprevir, telithromycin, troleandomycin, verapamil, voriconazole
  • Blood pressure medicines
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Use an effective form of birth control during treatment and for at least 12 weeks after you stop taking sirolimus.
• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, lung disease, high cholesterol, or any type of infection.
• This medicine may cause the following problems:
  
  • Increased risk of infection
  • Increased risk of cancer, including skin cancer and lymphoma
  • Poor wound healing
  • Kidney problems
  • Lung or breathing problems
  • Blood clotting problems
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Change in how much or how often you urinate, cloudy or bloody urine, painful urination, back or side pain
• Chest pain, coughing up blood, trouble breathing
• Confusion, weakness, tremors, problems with thinking or walking
• Fever, chills, cough, sore throat, body aches
• Lightheadedness, dizziness, fainting
• Skin changes or growths
• Swollen glands in your neck, armpits, or groin
• Rapid weight gain, swelling in your hands, ankles, or feet
• Unusual bleeding or bruising, pinpoint red spots on the skin, pale skin

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, constipation, stomach pain
• Joint or muscle pain
• Mouth sores

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088